March 16, 2017
Stem cell treatment blinds three women in Florida
While scientists have long hoped that stem cell therapy could be used to help patients suffering from neurodegenerative conditions, diabetes, heart disease, and other disorders, such treatments are not without risk, as several women have recently and very tragically discovered.
According to NPR and the New York Times, three elderly females with macular degeneration, a condition which causes vision loss, were suffered severe and permanent damage to their eyes and are now blind after undergoing an unproven series of stem cell treatments at a Florida clinic.As reported Wednesday in the New England Journal of Medicine, one of the women, a 72-year-old, went completely blind after doctors injected stem cells into her eye in an attempt to cure the disease. The others, ages 78 and 88, suffered some visual impairment but did not lose their sight completely – they could reportedly see well enough to drive, the Times explained.
Each of the patients went to a private clinic in Sunrise, Florida, where they paid $5,000 each to receive stem cell injections. Doctors used liposuction to remove fat from their bellies, then extracted stem cells from that fat into the patients’ eyes. The result was severe vision loss.
“In these three patients, the last documented visual acuity... before the injection ranged from 20/30 to 20/200,” the authors wrote. “The patients’ severe visual loss after the injection was associated with ocular hypertension, hemorrhagic retinopathy, vitreous hemorrhage, combined traction and rhegmatogenous retinal detachment, or lens dislocation. After 1 year, the patients’ visual acuity ranged from 20/200 to no light perception.”
Why this happened, and how you can avoid similar problems
According to the Times, the clinic was affiliated with a company then called Bioheart, which is now known as US Stem Cell. That firm’s chief science officer, Kristin C. Comella, told the paper that the clinic was not required to obtain FDA approval because it was treating patients with their own cells, which are not drugs, in a procedure similar to a patient receiving a skin graft.
The women said that they found US Stem Cell through a listing on clinicaltrials.gov, a website provided by the National Institutes of Health, and two of them later told doctors that they thought that they were participating in government-supported research. However, as the Times explained, clinical trials do not need government approval to approve on the clinicaltrials.gov site.
No trials ever actually took place, and while two of the patients filed now-settled lawsuits against the clinic, it faced no other penalties. Comella said that the clinic no longer treats eyes, but still uses stem cells to treat up to 20 other patients per week for problems such as degenerating spinal discs and torn knee cartilage. The case, NPR explained, is renewing calls for the FDA to address clinics that offer unproven stem cell treatments for vision loss and other medical conditions.
“One of the big mysteries about this particular case and the mushrooming stem cell clinic industry more generally is why the FDA has chosen to effectively sit itself out on the sidelines even as this situation overall grows increasingly risky to patients,” Paul Knoepfler, a stem cell researcher, told NPR via email. “The inaction by the FDA... puts many patients at serious risk from unproven stem cell offerings.”
NPR contacted the FDA, and was told by a spokeswoman that the agency is currently finalizing a series of new guidelines regulating how clinics could use stem cells for treatment purposes. In the meantime, the agency is encouraging those adversely affected by such procedures “to contact FDA and the appropriate state authorities in their jurisdictions to report any potentially illegal or harmful activity related to stem cell based products.”
Image credit: Dr. Thomas Albini